Manchester, 23 March 2009, DxS, a personalised medicine company, has CE Mark certification of the TheraScreen®: K-RAS Mutation Kit (CE-IVD) for use on Roche’s LightCycler® 480 Instrument II, allowing it to be sold for clinical use in the European Union. The test helps doctors to identify a patient’s K-RAS mutation status and response to anti-EGFR therapies for colorectal cancer. DxS also secured a license to provide Roche’s LightCycler® Adapt Software v1.1 to be used with its TheraScreen®: K-RAS Mutation Kits. The software allows automated processing of K-RAS mutation status tests for colorectal cancer patients.
Dr Stephen Little, CEO of DxS said: “This is excellent news for our customers. Not only do they have access to the TheraScreen®: K-RAS Mutation Kit, but they can now use the LightCycler® Adapt Software v1.1 for TheraScreen®: K-RAS Mutation Kit (CE-IVD)to help run the assay and interpret results, making our highly-sensitive K- RAS test the most user-friendly option currently available.”
LightCycler® Adapt Software v1.1 for TheraScreen®: K-RAS Mutation Kit (CE-IVD) is a specialised software package for use with the LightCycler® 480 Instrument II which provides automated data processing, avoiding manual interpretation and human error. The software generates data that is compatible with both LIMS (Laboratory Information Management System) and PMS (Patient Management System), and produces the results in a read-only format, ensuring patient’s results are secure. In addition, the software has a built-in warning system which generates a troubleshooting message if an assay has not been run correctly.
The LightCycler® Adapt Software v1.1 for TheraScreen®: K-RAS Mutation Kit (CE-IVD) is available for installation in territories where the TheraScreen®: K-RAS Mutation Kit (CE-IVD) is available for sale via Roche. These include Europe, Saudi Arabia, South Africa and Australia. Customers can ask their local Roche representative for further information.
Financial terms of the agreement are not disclosed.
DxS is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. Working in partnership with pharmaceutical companies to support the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics.
DxS has a continually expanding portfolio of cancer mutation products. The TheraScreen® range of CE-marked clinical diagnostic kits can identify genetic tumour mutations that affect how patients respond to cancer therapies, thus enabling doctors to provide the most beneficial treatment. DxS produces two clinical diagnostic kits, K-RAS and EGFR-29.
The TheraScreen®: K-RAS Mutation Kit (CE-IVD) is a companion diagnostic for Vectibix® (Amgen) and Erbitux® (Merck KGaA) for the treatment of colorectal cancer. DxS has an exclusive global distribution agreement with Roche Diagnostics for the distribution of the TheraScreen: K-RAS and TheraScreen: EGFR29 Mutation kits.
DxS’ pioneering real-time PCR technology Scorpions® is highly regarded for its proven speed and sensitivity, and is combined with ARMS (allele specific PCR) to develop each unique DxS product. This class-leading technology is also available for licence to diagnostic companies, for research, or for other varied applications.
DxS is a private, venture capital-backed company operating from the heart of Manchester’s Technology Quarter in the UK.
For further information please visit www.dxsdiagnostics.com